As consumers become increasingly empowered across sectors from retail to air travel, healthcare too must become more consumer-centric. In order to reach the up to 80% of moderate to severe cases of obstructive sleep apnea (OSA) that remain undiagnosed, one viable strategy is to remove pain points that slow or stop patients with the sleep disorder from being diagnosed.
Glimpses of several of these potential diagnostic technologies of the future were on display to SLEEP 2017 attendees in the poster hall. I noticed studies that compared developing technologies against the gold standard of polysomnography (PSG), and the early results are promising. If any of these diagnostic devices receive FDA approval, they may change the sleep medicine landscape of the next decade.
Somnarus Inc envisions a forehead-adhered disposable patch that weighs less than an ounce and records nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time, and body position. “It was most surprising to us how well this inexpensive miniature device performed in comparison with in-lab sleep studies,” said principal investigator Maria Merchant, PhD, CEO of Somnarus Inc, in a release about the poster, which found that in a study of 174 subjects the total rate of clinical agreement between “SomnaPatch” and in-lab PSG was 87.4% with 95% confidence interval of 81.4% to 91.9%.1
Consumer activity tracker Fitbit also presented a poster at SLEEP 2017. Sleep medicine professionals are typically in two camps regarding consumer products that purport to track sleep: one group says they are a boon to consumer awareness and ultimately to professional sleep medicine; the other says they are harmful due to insufficient evidence that they measure sleep with any accuracy.
The controversy will certainly continue, as this Fitbit-supported poster found that in 60 adult subjects, the wrist-worn devices that incorporate movement and cardiac sensors can be used to determine light, deep, and REM sleep stages with a reasonable degree of accuracy in normal adult sleepers. Conor Heneghan, PhD, lead sleep research scientist at Fitbit, said in a release, “The ability to easily track your sleep not only helps individuals better understand their own sleep, it also unlocks significant potential for us to better understand population health and gain new insights into the mysteries of sleep and its connection to a variety of health conditions.” The estimated Cohen’s kappa (the level of agreement greater than chance) was 0.52?±?0.14 for left hand wear, and 0.53?±?0.14 (right hand). The per-epoch accuracy (percent of epochs correctly labeled) was 69%.2
Even more relevant to sleep professionals is a June 20, 2017 article in which Heneghan tells CNBC that Fitbit is building tools to help diagnose and monitor sleep apnea utilizing optical technologies that shine a light into the skin. “We’re leveraging the fact that Fitbit has experience in optical electronics, and making them small and power efficient,” Heneghan told CNBC.3
Whether these emerging diagnostics will hold up in larger studies across varying patient populations remains to be seen, as does whether the results will translate smoothly from the laboratory to the consumer’s bedroom, ideally at an even better success rate than today’s home sleep testing devices. But one thing is for certain: continuing innovation holds the key to reaching more undiagnosed consumers.
Sree Roy is editor of Sleep Review. Email sroy[at]allied360.com.
1. Merchant M et al. Clinical validation of a diagnostic patch for the detection of sleep apnea. Sleep (2017) 40 (suppl_1): A166-A167.
2. Beattie Z. Estimation of sleep stages using cardiac and accelerometer data from a wrist-worn device. Sleep (2017) 40 (suppl_1): A26.
3. Farr C. Fitbit is developing devices for sleep apnea as dominance in fitness tracking wanes. CNBC. 20 June 2017.